Cleared Traditional

K101254 - NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

K101254 is an FDA 510(k) clearance for NEWFIX SCREW, manufactured by Tecnologia Y Diseno Industrial, S.A DE C.V. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K101254 · Tecnologia Y Diseno Industrial, S.A DE C.V · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
72d
Days
Class 2
Risk

K101254 is an FDA 510(k) clearance for the NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tecnologia Y Diseno Industrial, S.A DE C.V (South Lyon, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tecnologia Y Diseno Industrial, S.A DE C.V devices

FDA 510(k) Submission Details - K101254

510(k) Number K101254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date July 15, 2010
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 758
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K101254.
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